1. Field of the Invention
This invention relates to biotechnology and the creation of new probiotic preparations based on Bacillus-strain bacteria that can be used as prophylaxis and treatment of infectious diseases and dysbiosis of different origin of human, farm livestock and poultry.
2. Discussion of Related Art
Biopreparations based on Bacillus-strain bacteria are well-known. Biopreparations: probiotics based on Bacillus-strain bacteria contain strains possessing various spectrum of antibacterial and antifungal activity. The effectiveness of these preparations is determined by the width of spectrum and its antibacterial activity contained in strains preparation.
The probiotic Bactisubtil (“Marion Merrell” Company/France/) and its analogue Flonivin (“Galenika” Company/Yugoslavia/) are wide spread in medical practice in the West Europe countries. They contain the culture of strain B. cereus IP 5832 (collection of Institute Pasteur (Paris)). Well-known Vietnamese preparation Biosubtyl contains the strain B. subtilis as an active component.
The base of Enterogermina (“Sanofi Winthrop” Company, Italy) is the culture B. clausii. 
The biopreparation Cereobiogen (“Xing Lap” Company, China) is also well-known. The effective agent of it is B. cereus DM-423 (V. V. Smirnov, S. R. Reznik, I. B. Sorokulova, V. A. Vyunitskaya. Questions for discussion of creation and application of bacterial preparations for micro flora correction of homoiothermal animals: Microbiological Journal, 1992, volume 54, N->6, p. 82-93).
One disadvantage of these probiotic preparations is the restricted spectrum of treatment activity as they are aimed against a small group of pathogenic bacteria.
Medical preventive biopreparation Bactisporin for treatment of broad spectrum of diseases, containing lyophilized biomass of the strain Bacillus subtilis 3H and protective media on the base of saccharose-gelatine formula and lactose (Patent RU N° 2130316, A61K 35/66, published on 20.05.1999).
However, the biopreparation Bactisporin is not efficient against a set of acute enteropathogenic bacteria, for example, caused by the bacteria of stem Pseudomonas spp., Streptococcus spp., Enterococcus spp.
Biopharmaceutical preparation Deprecan A, containing recombinant strain of Bacillus subtilis is well-known and produces α-2-interferon of the human, strain Bacillus licheniformis and an excipient. The preparation can contain recombinant strain of Bacillus subtilis BKPM (M) No.-7289. The preparation has antibacterial, antiviral and immunomodulatory activity and can be used while treating various diseases of infectious and noninfectious nature (Patent RU No. 2158134, A61K 35/74, published on 20.09.2000).
However, Deprecan A contains recombinant strain of plasmid, determining resistance to kanamycin, but this does not meet the requirements of World Health Organization.
A well-known preparation Biosporin is used prophylaxis and the treatment of gastrointestinal diseases of human, and contains the vital cells of strains Bacillus subtilis 3 (VKPM (BKΠM, “All-Russian Collection of Industrial Microorganisms”) No. B-2335) and Bacilllus licheniformis 31 (VKPM, No. B-2336) and a vehicle (Patent SU No. 1722502, A61K 35/74, published on 30.03.1992).
Biosporin is characterized by the high antagonistic activity to the wide spectrum of pathogenic and opportunistic microorganisms (Sorokulova I. B., 1997).
One disadvantage of Biosporin is that strains contained are susceptible to antibiotics. Therefore this preparation is not recommended to be used together with antibiotics when treating.
The closest analogue is the preparation against viral and bacterial infections, containing the mixture of biomass of strain Bacillus subtilis BKPM No. B-7092, Bacillus subtilis BKPM No. B-7048, Bacillus licheniformis BKPM No. B-7038 in its spore form with the titre of not less than 3×1010 spore/g, and stabilizer, that is, starch and sucrose. (Patent RU No. 2142287, A61K 35/74, published on 10.12.1999).
One disadvantage of the well-known preparation is the use of the recombinant strain, containing plasmid, determining resistance to antibiotics.
Among the preparations of veterinary application strain Bacillus subtilis X-15 is known and is used for prophylaxis and treatment of cow's endometritis (Patent RU No. 2180575, C12N 1/20, published on 20.03.2002).
One disadvantage of the preparation on the base of stain Bacillus subtilis X-15 is the restricted action spectrum as it is active against a small group of microorganisms, causing the cow's endometritis.
A probiotic preparation Subtilis is also known and is based on liquid or lyophilized freeze-dried strain culture Bacillus subtilis VKM No. B-2250 D. This preparation is designed for prevention and treatment of gastrointestinal diseases of animals, birds and fish, and it increases the feed absorbency and increases producing capacity and weight gain (Patent RU No. 2184774, C12N 1/20, published on 10.07.2002).
One disadvantage of the preparation Subtilis is its restricted spectrum of antagonistic activity.
The closest analogue is the probiotic preparation of compound action, containing the following components, vol. %: mixture of biomass Bacillus subtilis VKPM No. 4759 with the titer 1×107-1×109 of live microbial cells and biomass Bacillus licheniformis 2336/105 with the titer 1×108-10×10 of live microbial cells in 1 ml of normal saline 92 to 98%, and stabilizer based on serum of the cattle's blood or milk or its mixture, sucrose and gelatin of 2 to 8%. The preparation possesses antibacterial and antiviral activities and is capable for prolonged synthesis of interferon in various parts of open body cavities. (Patent RU No. 2159625, A61K 35/66, published on 27.11.2000)